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484
Volume 14 | Number 4 | April 2012 | GENETICS in MEDICINE
special article ©American College of Medical Genetics and Genomics
Managers of genomic biobanks constantly face ethical and legal chal-
lenges ranging from issues associated with the informed consent pro-
cess to procedural concerns related to access by researchers. Yet, with
the availability of next-generation sequencing technologies, one topic
is emerging as the focus of ongoing debate: the return of individual
research results and incidental ndings to participants. is article
examines this topic from an international perspective, where poli-
cies and guidelines discussing the matter in the context of genomic
biobanks and genomic research are analyzed and commented. is
approach aims to highlight the shortcomings of these international
norms, mainly the danger arising from both the therapeutic miscon-
ception and the conation of research results with incidental ndings.
is article suggests some elements to consider in order to comple-
ment available guidance at the international level.
Genet Med 2012:14(4):484–489
Key Words: biobanks; general research results; genomic research;
incidental ndings; individual research results; international norms
1Faculty of Medicine, Human Genetics Department, McGill University, Montreal, Quebec, Canada; 2Centre of Genomics and Policy, Montreal, Quebec, Canada.
Correspondence: Ma’n H. Zawati (man.zawati@mcgill.ca)
Submitted 28 November 2011; accepted 17 January 2012; advance online publication 16 February 2012. doi:10.1038/gim.2012.13
Genomic biobanks have been identied as “vital research tools
in the drive to uncover the consequences of human health and
disease.”1 ese organized collections of human biological mate-
rial and associated data2 have even been described as one of the
top 10 ideas changing the world.3 With scientists recognizing
that common diseases result from a multitude of interactions
between genetic variation, lifestyle behaviors, and the environ-
ment, there has been a rise in the number of biobanks in the
past decades, especially in large-scale genomic studies (over
10,000 individuals), which aim to produce aggregate ndings
derived from the data and samples of groups of persons.4 e
collection of data and samples and their analysis in the context
of biobanks have traditionally led to debates about the return
of individual research results (IRRs) to participants.5 Although
some biobanks limit feedback to general results (sometimes
called “aggregate results”),6 others that recruit through physi-
cians may return individual ndings to research participants.7
For the purposes of this text, IRRs are results discovered during
the course of a research project—and within its objectives—that
concern an individual participant and have potential health or
reproductive importance.8
With next-generation sequencing technology producing vast
amounts of data, the debate has become more complex due to
the ensuing increase in incidental ndings (IFs) in research.9
IFs are dened as ndings concerning a research participant
that have potential health or reproductive importance and are
discovered during the course of research but are outside the
objectives of the project.10 e rise of data-intensive science
stemming from the use of high-throughput technology has led to
a debate on the pertinence of returning IRRs and IFs in genomic
biobanks.11–13 Although most of these debates are jurisdiction-
specic, how is the issue of the return of IRRs and IFs reected
in international norms? What trends, if any, are discernable?
e term “international” refers to laws, guidelines, and policies
emanating from non-US countries and international organiza-
tions. Analyzing the issue of return of IRRs and IFs from an
international perspective will serve to highlight current trends
as well as the factors inuencing possible future change.
METHODOLOGY AND RESULTS
e international documents retrieved and referenced in this text
were collected using the PopGen Module (http://www. popgen.
info) of the HumGen International Database (http://www.
humgen.org), a database of international, national, and regional
guidelines and policies specic to human genetic research. e
PopGen module is a specialized database composed of laws,
guidelines, policies, and literature addressing the legal and ethi-
cal issues in biobanks generally and population biobanks more
specically. For the purpose of our research and in order to
focus only on pertinent documents, the keywords “biobanks”
and “communication of results” were used. Keywords such as
“research result” or “incidental ndings” were not available. All
organizations were selected, and no limitations were set as to
jurisdiction. is provided a large selection of documents. Only
English documents dating from 1985 to 2011 (the default date
restriction) were queried. is search resulted in 149 results.
US documents were removed from the list of documents
retrieved, which reduced the number of results to 125. A thor-
ough analysis of the remaining documents further narrowed
the number of laws, policies, and guidelines pertinent to the
International normative perspectives on the return
of individual research results and incidental
findings in genomic biobanks
Ma’n H. Zawati1,2 and Bartha Maria Knoppers1,2
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GENETICS in MEDICINE | Volume 14 | Number 4 | April 2012
Perspectives on the return of research results and incidental findings | ZAWATI and KNOPPERS special article
return of IRRs and IFs to 15. is small number was expected,
given that the term “communication of results” covers a wide
array of feedback procedures and communication is not limited
to research results or IFs. Moreover, many of these documents
mention IFs or research results but do not provide guidance.
e nal list (Ta b le 1 ) includes both laws and guidelines. Laws
are binding, whereas guidelines are generally nonbinding but
may be considered professional norms.14
THERAPEUTIC MISCONCEPTION
erapeutic misconception15 occurs when a “research sub-
ject … inaccurately attributes therapeutic intent to research
procedures.”15 It has been argued that alluding to the possible
future disclosure of any IRRs and IFs promotes the therapeu-
tic misconception. Indeed, the Singapore Bioethics Advisory
Committee’s 2002 Human Tissue Research Report16 maintains
that “… donors should not expect any personal or direct benet
from the donation of tissue, including information of any medi-
cal condition or predisposition or likelihood of such discovered
in the course of research on the sample. Likewise, researchers
and tissue bankers should not be under an obligation to dis-
close such information to the donors, unless they have agreed
to do so in advance of the donation.”16
e Singapore Bioethics Advisory Committee reiterates this
stance in its 2005 document, titled Ethical, Legal and Social
Issues in Genetic Testing and Genetic Research.17 It posits that
since “human genetics research enhances our understanding of
the genetic basis of disease and how genetic and environmental
factors inuence one’s health,”17 the main goal is not to oer
research participants or their families “specic information
about their genetic status or health.”17 is “no-return” policy
is not new to the biobanking eld and is largely followed by
large-scale, longitudinal population biobanks that are mainly
epidemiological in nature.18–22 Yet large-scale biobanks do pro-
vide their participants with feedback at assessment—which is
provided as a matter of course and should not be confused with
eventual IRRs, and more importantly, should not be considered
equivalent to a medical checkup.23
Table 1 List of international documents retrieved and referenced
Title of document Organization(s) Ethics norm Legislation
1. Biobanks for Research, 2004 German National Ethics Council X
2. Ethical, Legal and Social Issues in Genetic Testing
and Genetic Research, 2005
Singapore Bioethics Advisory Committee X
3. Genetic Databases: Assessing the Benefits and
the Impact on Human & Patient Rights, 2004
World Health Organization: European Partnership on
Patients’ Rights and Citizens’ Empowerment
X
4. Guidelines for Genetic Biobanks, 2004 Italian Society of Human Genetics X
5. Guidelines for Human Biobanks and Genetic
Research Databases (HBGRDs), 2009
Organization for Economic Co-operation and
Development
X
6. Guidelines for Human Biobanks, Genetic
Research Databases and Associated Data, 2010
Australian Office of Population Health Genomics—Public
Health Division
X
7. Human Biobank Management Act, 2010 Government of Taiwan X
8. Human Biobanks for Research, 2010 German National Ethics Council X
9. Human Genes Research Act, 2000 Government of Estonia X
10. Human Tissue Research, 2002 Singapore Bioethics Advisory Committee X
11. International Ethical Guidelines for Epidemiological
Studies, 2009
Council for International Organizations of Medical Science X
12. Joint Statement on the Process of Informed
Consent for Genetic Research, 2008
Canadian College of Medical Geneticists and Canadian
Association of Genetic Counselors
X
13. Law 14/2007 of 3 July on Biomedical Research, 2007 Government of Spain X
14. Medical Technology: Health Surveys and
Biobanking, 2004
Norwegian University of Science and Technology X
15. Tri-Council Policy Statement: Ethical Conduct
for Research Involving Humans, 2010
Canadian Institutes of Health Research, Natural Sciences
and Engineering Research Council of Canada, and the Social
Sciences and Humanities Research Council of Canada
X
In 12 of these 15 documents (all except 5, 6, and 11), two main trends were discerned: concern with the issue of therapeutic misconception, and the
conflation of different types of results and findings. The remaining three documents are addressed in the discussion on Elements to Consider in order to
improve and complement current international guidance.
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special article
at being said, it could be argued that the risk of therapeutic
misconception engendered by return of results can be lessened
if limited to disclosure of ndings in exceptional cases where
they are analytically valid, clinically signicant, and medically
actionable.23 It is policies that mandate broader and imprecise
obligations that constitute a greater risk. Witness the 2010
Canadian Tri-Council Policy Statement: Ethical Conduct for
Research Involving Humans,24 which states that “researchers
have an obligation to disclose to the participant any material
incidental ndings discovered in the course of research.”24 In
this text, material IFs are dened as having “signicant welfare
implications for the participant, whether health-related, psy-
chological or social.”24 Return of these ndings is described as
an ethical “obligation.” e statement does, however, encour-
age researchers who “are unsure of how to interpret ndings
or uncertain whether ndings are material”24 to consult with
colleagues or refer to standards in their discipline. ere could
be several practical limitations to such a broad approach in the
biobanking eld, especially with the presence of privacy and
condentiality clauses in access agreements signed by research-
ers wishing to use biobanks.25 Faced with an open-ended ethi-
cal obligation, researchers might be inclined in cases of doubt
to systematically disclose ndings. If so, rather than reecting
an exceptional situation, the disclosure of ndings may well
become the rule in cases of uncertainty, hence indirectly pro-
moting the therapeutic misconception.
THE CONFLATION OF RESEARCH RESULTS
AND INCIDENTAL FINDINGS
Another visible trend in some of the international documents
reviewed was the tendency to conate various notions, such as
(i) general research results with IRRs, (ii) the return of IRRs
with IFs, and (iii) the return of IRRs and IFs with the legal duty
to rescue.
General research results versus IRRs
General research results and individual results are distinct, as
are as well the modalities and conditions for their return.23 As
mentioned earlier, IRRs concern an individual participant and
general research results concern a group of persons. Whereas
general results are largely returned through newsletters and
websites,26 IRRs are returned per the policies of the biobanks
as reected in their informed consent forms and information
brochures.27
Yet, while dierences between these two types of results
are obvious, some international norms conate the two. One
example of such confusion can be found in the Italian Society of
Human Genetics’ 2004 Guidelines for Genetic Biobanks,28 which
state that the research participant “should have the possibility to
take separate decisions regarding whether: to wish/not wish to
be informed about the results or diagnostic possibilities deriv-
ing from continuing research.”28 It is not clear whether the term
“results” refers to general or IRRs. e issues associated with
the return of individual as opposed to general results are not the
same, and conating the two can lead the research participants
to expect future notice of both types of results—an expectation
that could sometimes turn out to be groundless. at being
said, this lack of clarity could be the result of a modest transla-
tion of this document from Italian by the country’s Society of
Human Genetics.
Along the same lines, the opinion of the German National
Ethics Council’s 2004 Biobanks for Research29 species that it
would involve unacceptable eort and expense to inform donors
of “all results of the research.”29 Although later discussing “per-
sonal results,”29 the document is not consistent in dierentiating
between general and IRRs. However, the German council’s
2010 opinion on Human Biobanks for Research clearly species
“individual research results”30 in its text, which lists the report-
ing of such results as an occasion “for the donor to be contacted
again in the future.”30
IRRs versus IFs
e dierence between IRRs and IFs ultimately relates to the
objectives associated with the research project in question.
Nonetheless, many international norms do not explicitly distin-
guish between them. An interesting example is Estonia’s 2001
Human Genes Research Act,31 which states that gene donors
might not always want “data on hereditary characteristics and
genetic risks obtained as a result of genetic research.”31 is Act
uses the word “risks,” which could emanate from IRRs or IFs.
e Norwegian University of Science and Technology’s 2004
Medical Technology: Health Surveys and Biobanking32 uses a
similar term when it species that “some individuals could pos-
sibly benet by being contacted when unexpected genetic risks
for future disease were discovered.”32
In 2008, the Canadian College of Medical Geneticists and
Canadian Association of Genetic Counsellors adopted a
Joint Statement on the Process of Informed Consent for Genetic
Research.33 is document states that if individual results are
to be disclosed, then participants should be made aware that
“unexpected results” could be obtained.33 It is unclear whether
this joint statement refers to IRRs or IFs more specically, or
even both.
e same could be said of Taiwan’s 2010 Human Biobank
Management Act,34 one of the few Asian laws on biobanks.
e Act discusses the need for the research participants to be
made aware of “any possible impacts of the genetic informa-
tion derived from the biological specimens on the participant,
and his/her relatives or an ethnic group.”34 Here again, the term
“genetic information” is broad and it is unclear whether this
refers to IRRs or to IFs.
Although the conditions for returning IFs and IRRs may
be similar,8 an important dierence lies in the expertise of the
researchers handling them. In the case of research results, the
researcher is usually competent to interpret them. e same
cannot be said for IFs, which are not only largely clinical in
nature, but could also fall outside the particular eld of exper-
tise of the researcher who discovered them. Echoing a similar
concern in the erapeutic Misconception section, a cona-
tion between IRRs and IFs could create arduous responsibilities
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for researchers and prompt some of them to return potentially
important health information that may be discovered—
although originally unexpected—for fear of liability.14,35
Return of IRRs and IFs versus legal duty to rescue
e duty to rescue is a tradition found in many civil law juris-
dictions and oen carries penal sanctions. Generally, this duty
is characterized as an obligation to provide assistance to an indi-
vidual whose physical integrity is in peril.36 In other words, there
needs to be a situation where an identiable individual is faced
with immediate danger. Although not explicitly addressing
the duty to rescue, the World Health Organization’s European
Partnership on Patients’ Rights and Citizens’ Empowerment’s
2004 report37 generally reects the legal stance in Europe. It
states that because “research includes matters of unknown
future import, sometimes unexpected ndings can be gener-
ated”;37 and when “an immediate and clear benet to identiable
individuals can be achieved … [which] will avert or minimize
signicant harm to the relevant individuals,”37 such ndings
should be returned. Another example comes from the Spanish
2007 Law on Biomedical Research, where the participant’s right
“not to know” about IFs is armed.38 is law allows a close
family member or a representative to be informed of IFs if this
will avoid a serious damage to the health of the participants or
that of their biological family.38
Although some authors have reconciled the notion of return
of ndings with an ethical duty to rescue,39 this article posits
that the legal duty to rescue is not a solid basis for a duty to
return research results and IFs. Currently, ve criteria for return
dominate the debate on the return of IRRs and IFs:
1. “e ndings are analytically valid;
2. Returning them to the donor comports with applicable
law …;
3. e donor has been oered the option of consenting to
return of individual ndings … and has opted to receive
them;
4. e ndings reveal an established and substantial risk of
(a) a serious health condition, or (b) a serious condition of
reproductive importance …; and
5. e ndings are actionable … .”8
It is conceivable that situations giving rise to a duty to rescue
could satisfy these conditions, but that will not always be the
case. One of the issues here is participants’ right not to know.
Unless explicitly mentioned—as in the Spanish biomedical
research law—the element of consent and the right not to know
are generally not at the forefront of decisions based on a duty
to rescue. As mentioned earlier, what characterizes the duty to
rescue is the seriousness and urgency of the situation. Rarely
is genetic information “urgent.” Moreover, what happens when
participants have clearly consented not to receive IRRs or IFs?
Using the concept of a duty to rescue in this case could be prob-
lematic, as it may ignore the participant’s decision not to know.
In an eort to provide consistent and harmonized guidance to
researchers for the return of IRRs and IFs, the concept of the
duty to rescue also falls short because it is not a legal obligation
in all jurisdictions.23
Finally, another potential diculty in using the concept of
duty to rescue as a basis for the return of IRRs and IFs is the prac-
tical limitations associated with the nature of some biobanks.
In large-scale, longitudinal population studies—where sam-
ples and data are collected and stored for future unspecied
research, for example—it will be dicult to apply the urgency
criterion once the data and samples are stored, given that dis-
covering ndings that satisfy the requirement of a legal duty to
rescue is hypothetical and could stretch over time.
UNTYING THE GORDIAN KNOT:
ELEMENTS TO CONSIDER
Our comparative review of international normative guidance
provides an interesting perspective that complements the anal-
ysis of issues in specic jurisdictions. As biobanking becomes
more international, such a review is necessary. at being said,
it is clear from the sections on erapeutic Misconception and
e Conation of Research Results and Incidental Findings
that the existing international norms pertinent to the return of
IRRs and IFs are not consistent. ey use ambiguous terminol-
ogy and conate dierent concepts. Creating a lexicon covering
IRRs and IFs has been proposed.40 It is necessary, however, that
such a lexicon be adopted or adapted by international orga-
nizations through a mechanism similar to the International
Conference on Harmonization.41 Such a guidance document
could include clear denitions of terms such as IFs, return of
results, and clinical utility. is lexicon, if disseminated inter-
nationally, would provide much needed consistency in interna-
tional norms and could reduce ambiguity and contradictions.
Moreover, it is important for any international guidelines
on the matter to provide recommendations on the decision-
making process leading to the return of IRRs and IFs, similar to
the one proposed by the Working Group recommendations in
this issue8 and the 2010 National Cancer Institute Workshop on
the Release of Research Results to Participants in Biospecimen
Studies.27 Indeed, future guidelines should include practical
considerations for establishing analytical validity, assessing the
seriousness of the risk, and concretizing actionability, while
recognizing the dierent types of studies involved, a point we
will clarify in the following.
at being said, any future international guidance document
should uphold the discretion of researchers, as evident in docu-
ments such as the Council for International Organizations of
Medical Sciences’ 2009 International Ethical Guidelines for
Epidemiological Studies,42 the 2009 Organization for Economic
Co-operation and Development Guidelines on Human Biobanks
and Genetic Research Databases43 and the Australian Oce
of Population Health Genomics’ 2010 Guidelines for Human
Biobanks, Genetic Research Databases and Associated Data.44
While oering practical guidance on establishing analytical
validity, and on the seriousness of risk and actionability, some
discretion should be provided to researchers to determine
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whether ndings satisfy these conditions. Due to the potential
scientic uncertainty of some ndings,45 such an approach
would provide researchers with much needed professional
leverage and avoid both stringent and open-ended obligations.
Finally, when one scrutinizes the scope of the international
guidance available on the return of research results and IFs,
it becomes clear that they are not homogeneous: some pro-
vide guidance for research at large; others are specic to tissue
biobanking or genetic research. Dierences are therefore under-
standable. We echo calls for distinguishing dierent contexts as
concerns the return of ndings to participants, based on the
nature of the study in question.46 In fact, although it is impor-
tant to remain consistent with the general provisions existing
in the majority of laws, regulations, policies, and guidelines,
homogeneous approaches to the micromanagement of IRRs
and IFs at the international level risk harming the integrity,
credibility, and transparency of research.25 For example, impos-
ing the same modalities on the return of IRRs and IFs that are
currently applicable in clinical trials on the broader infrastruc-
ture resource mission of population biobanks could undermine
their longitudinal design to say nothing of the altruistic nature
of the contribution of a citizen of a given country. is could
inadvertently create unrealistic participant expectations and
limitless, undened duties for researchers.
CONCLUSION
We discern two trends from our analysis. In a culture of height-
ened attention to IRRs and IFs, lack of specicity in obligations
promotes professional confusion as well as the therapeutic mis-
conception. Second, the tendency to confuse notions, such as
general versus individual results, research results versus IFs,
and the return of ndings versus the duty to rescue, slows prog-
ress. ree key innovations are needed to address the elements
to consider identied in the section on Untying the Gordian
Knot: Elements to Consider. First, it is important to encour-
age endeavors that aim to provide a clear set of denitions
related to the return of IRRs and IFs at the international level.
is will allow for much needed consistency in international
norms and will reduce ambiguity and contradictions. Second,
clear practical guidance establishing the principal conditions
for the return of ndings, such as analytical validity, serious-
ness of the risk, and actionability must also be oered at the
international level. is will create an important and consistent
approach for researchers working in international biobank-
ing initiatives across various jurisdictions. Finally, approaches
to IRRs and IFs will need to reect the types of biobanks and
their contexts as well as the nature of the participation in ques-
tion. Indeed, when proposing norms for the return of IRRs and
IFs, the key will be to provide simple criteria that do not cover
all possible situations but instead distinguish between the dif-
ferent research objectives and contexts. e Public Population
Project in Genomics and Society provides a recent example of
this.47 At a time when it is perceived as increasingly dicult to
establish the scientic certainty of genomic ndings—where
“distinctive cultures with respect to interpreting and reporting
results” 48 exist—specicity, clarity, and transparency in policy
will provide proper guidance that can bolster the trust of par-
ticipants who altruistically contribute their data and samples
for research.25
ACKNOWLEDGMENTS
The authors acknowledge the financial support of the National
Institutes of Health, National Human Genome Research Institute
grant no. 2-R01HG003178, and the Canadian Partnership Against
Cancer. The authors also thank Adrian Thorogood and Supriya
Dwivedi for their assistance.
DISCLOSURE
The authors declare no conflict of interest.
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